Trial Information

Prospective Study of Potential Factors Affecting Weight in Breast Cancer Patients Receiving Adjuvant Chemotherapy

OBJECTIVES: I. Evaluate the relative contributions of factors that may lead to weight gain
in breast cancer patients receiving adjuvant chemotherapy. Factors examined include:
Hormonal and growth factor status (follicle stimulating hormone, total, bound, and free
estradiol, androgens, sex hormone binding globulin, thyroid hormones, prolactin,
insulin-like growth factors I and II, and plasma leptin) Factors affecting energy intake or
expenditure (oral intake, physical activity, and resting metabolic rate) Psychological
factors (depression and quality of life) II. Evaluate the effect of chemotherapy on
hormonal and growth factor status in these patients.

III. Assess the impact of chemotherapy on bone marrow density in these patients.

PROTOCOL OUTLINE:

Data is collected from women diagnosed with primary breast cancer at 3 points (5 visits):
(i) after breast cancer surgery, but before chemotherapy begins (2 visits to NIH day
hospital 1 week apart); (ii) 2-3 weeks after chemotherapy has ended (2 visits, 1 week
apart); and (iii) 6 months after chemotherapy has ended (1 visit). Tests conducted during
these visits include evaluation of blood for hormones, growth factors, and leptin; body
composition by DXA; visceral and subcutaneous abdominal adipose tissue by an axial CT scan;
and evaluation of resting metabolic rate and daily energy expenditure by a single
administration of doubly labeled water at visits "a" and "b" during data collection
timepoints 1 and 2. Questionnaires assessing epidemiologic risk factors for breast cancer,
dietary intake, physical activity, depression, and quality of life are also administered at
the three timepoints.

PROJECTED ACCRUAL:

A total of 140 patients will be accrued for this study within 1-2 years.